NCT03681405

Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery

Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well two different supportive programs work in supporting optimal recovery in participants undergoing gynecological surgery. Supportive programs use different methods for helping participants cope with the surgical experience including gentle movements, counseling, writing, or relaxation techniques, and may help improve participants' well-being after gynecological surgery.

Detailed description

PRIMARY OBJECTIVES: I. To calculate recruitment, adherence, assessment completion, and retention rates. SECONDARY OBJECTIVES: I. Document the frequency of adverse events. II. Assess descriptive data on proposed outcomes (i.e., pain, sleep disturbances, psychological distress) for the next phase of study.) III. Qualitatively assess acceptability to guide future study planning. OUTLINE: Participants are randomized to 1 of 2 groups. GROUP I (MINDFUL MOVEMENT AND BREATHING \[eMMB\]): Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery. GROUP II (ATTENTION CONTROL \[AC\]): Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.

Conditions

• Ovarian Neoplasm
• Uterine Neoplasm

Interventions

Type	Name	Description
OTHER	Informational Intervention	Given information about mindful movement and breathing
OTHER	Questionnaire Administration	Ancillary studies
BEHAVIORAL	Telephone-Based Intervention	Receive caring attention phone call

Timeline

• Start date: 2018-12-07
• Primary completion: 2020-04-09
• Completion: 2020-04-09
• First posted: 2018-09-24
• Last updated: 2021-11-08
• Results posted: 2021-06-24

Locations

1 site across 1 country: United States